CN111356519A

CN111356519A - Testing a reverse osmosis installation for use in a dialysis apparatus

Info

Publication number: CN111356519A
Application number: CN201880073181.7A
Authority: CN
Inventors: 克里斯蒂安·鲁夫; 托马斯·波尔; 米夏埃尔·维尔德
Original assignee: Fresenius Medical Care Deutschland GmbH
Current assignee: Fresenius Medical Care Deutschland GmbH
Priority date: 2017-11-13
Filing date: 2018-11-12
Publication date: 2020-06-30
Also published as: US20190143273A1; US20200294648A1; EP3710140A1; KR20200079501A; DE102017126592A1; WO2019092232A1; US10913031B2; EA202091192A1; BR112020009396A2

Abstract

The invention relates to an electronic safety system for a RO installation (RO) designed for use with at least one dialysis device (D). To this end, the system comprises: an RO facility (RO) which determines that a sensor unit (S) for detecting sensor data is configured for preparing ultrapure water, and wherein the RO facility (RO) comprises an electronic data interface (RO-S) for transmitting the sensor data detected by the sensor unit (S); and further comprising an analysis device (AE) which is intended for analyzing the water samples of the RO installation with respect to safety requirements and in particular with respect to contamination and for generating result data, wherein the analysis device (AE) is also designed with an analysis interface (AE-S) in order to transmit the generated result data in electronic form; a Network (NW) for exchanging data between medical technology devices, in particular between a RO facility (RO) and an evaluation device (AE).

Description

Testing a reverse osmosis installation for use in a dialysis apparatus

Technical Field

The invention is in the field of water technology in the medical field and relates in particular to the safety check of reverse osmosis installations for medical technology installations, in particular dialysis installations, in order to be able to provide the required water in a sufficiently quality and (bacterial) contamination-free manner. The invention relates in particular to a system, an analysis device, a reverse osmosis installation, a server and a method for safety checking of delivered water, and a computer program product.

Background

The dialysis apparatus is operated with the aid of ultrapure water. In order to be able to supply ultrapure water, a reverse osmosis plant (abbreviated hereinafter on the basis of the English name: RO plant) is used.

The basic physical principle of reverse osmosis is used to concentrate substances dissolved in a liquid. The natural osmosis process is reversed by pressure. Schematically, the RO process can be described such that two containers are filled with liquids of different substance content, and in particular salt content (for example) water, which containers are separated from one another by a semipermeable membrane. After the use of osmotic pressure in the vessel in which the concentration is to be increased, the molecules of the solvent are able to migrate against their "natural" osmotic propagation direction. The pressure applied must be higher than the pressure which results from the osmotic requirements for concentration equalization. This method presses molecules of solvent into compartments where a less concentrated dissolved substance is present. That is, by this method, the concentration of the undesired substances on the pure water side is reduced.

In the medical field, and in particular for operating dialysis devices, such as the hemodialysis system 5008 of the fisheries medical treatment and other extracorporeal blood treatment devices, the water produced by means of the RO facility is required and transported there.

In order to comply with the stringent safety requirements of medical devices, it is absolutely necessary to supply water in the required quality. For this purpose, it is checked at defined time intervals whether the ultrapure water produced by the RO plant complies with the chemical and microbiological safety requirements. This was done in an external laboratory. The conditions for the examination are defined in standard ISO 23500 "guidelines for the preparation and quality management of fluids for hemodialysis and related therapies" (guidelines).

Typically, a sample of ultrapure water is extracted from the RO facility or connected loop and sent to a laboratory. The laboratory typically takes days to provide laboratory reports or results, which in the prior art are forwarded to the operator of the RO facility by mail or telephone call.

However, the above-mentioned method according to the prior art has drawbacks that cannot be ignored: sometimes lasting days or until a week, do not provide laboratory results at the local facility. If the result indicates, for example, that there is a bacterial pathogen contamination or other safety failure, the connected dialysis equipment can be switched off from the RO facility only after the information is forwarded locally to the RO facility. There is a safety risk during this time period because the plant continues to operate with poor water quality. In this case, therefore, the methods hitherto have shown safety drawbacks.

Disclosure of Invention

Based on the known methods according to the prior art, it is therefore an object of the present invention to improve the safety of RO installations and medical technical devices connected thereto. Furthermore, the analysis capability of the collected test data (sensor data, laboratory values, etc.) should be improved. Furthermore, the data relating to security should be provided earlier. Furthermore, the provided information should be improved by means of technical notifications and be directly usable locally on the device.

The object is achieved according to the invention by an electronic safety system, an analysis device, an RO installation, a server and a method for safety checking delivered water as well as a computer program product according to the enclosed, mutually parallel independent claims.

In the following, the invention is described in terms of a solution to the stated object in terms of a system, and in particular in terms of a security system. The features, advantages, or alternative embodiments mentioned herein are equally applicable to other claimed subject matter and vice versa. In other words, further subject claims (for example for an analysis device, RO installation or server) and method claims can also be improved by means of the features described and claimed in connection with the system. The respective functional features of the method are formed by the respective subject module, in particular by an electronic hardware module or a microprocessor module of the system or of the device, and vice versa.

According to a first aspect, the invention relates to an electronic safety system for an RO system, wherein the safety system can be operated as a central server-based and in particular cloud-based system to ensure a sufficient ultrapure water quality, and wherein the RO system is designed for use and/or operation in connection with medical technology equipment, in particular dialysis equipment. The security system includes:

an RO facility which is intended for producing ultrapure water and which is designed with a sensor unit for detecting sensor data, in particular with a retention rate

And wherein the RO plant comprises an electronic data interface for exchanging analogue and/or digital data, in order to send sensor data detected by the sensor unit to an external entity outside the RO plant;

an analysis device which can be configured, for example in a laboratory with a laboratory device, for checking or analyzing the water quality of a water sample of an RO facility with regard to safety requirements for ultrapure water (for example with regard to contamination), and which can determine results for generating result data as a response to the analysis of the water sample, wherein the analysis device is further configured with an analysis interface for electronically transmitting the generated result data to an external entity located outside the analysis device;

a network for data exchange between the medical-technical devices of the security system, in particular between the RO installation and the analysis device.

According to a preferred embodiment, the system comprises a server which determines sensor data for receiving the RO system and/or result data of the evaluation device and which also determines a device for forwarding the result data for control purposes to the RO system and/or to a medical technology system connected to the RO system. If necessary, the result data can also be forwarded to a further device, which is integrated in the respective unit (clinic/hospital department) in which the RO facility is installed. An advantage of this embodiment of the invention is that the server can be configured in the cloud and thus always provide sufficient technical resources (e.g. processor power, memory capacity, execution of applications, for example for evaluation purposes). Furthermore, a central processing and data aggregation can thus be achieved, in which the generated data can be transferred quickly and early to peripheral clients (e.g. medical technology devices, RO facilities) via a network connection or a corresponding control interface.

Another important technical advantage is that the RO plant and/or e.g. the dialysis equipment can be manipulated or adjusted directly from the result data. If the result data indicate, for example, a deficiency in water quality, it can be forwarded as early and directly to the receiving device, i.e. for example the dialysis device, in order to disconnect the dialysis device from the RO water system or, if possible, be replaced by another interface. Furthermore, the evaluation device on the server can access a rule base which can also be adjusted dynamically during operation, in which the following rules are provided, for example defining: an alarm notification is generated in case of a fault and sent to a different computer-based or electronic receiving account (e.g. a mobile terminal device of a ward doctor or a computer in a nurse's station) in order to enable fast measures.

The server with the evaluation application is furthermore capable of receiving further data from other data sources, such as a water supply unit determined for delivering water to the RO facility, or other devices connected to or supplied by or operated by the RO facility. The water supply unit can be configured with a measuring unit in order to detect the water consumption data and forward it to the server. According to a preferred embodiment of the invention, the server is already able to provide the first result on the basis of the forwarded water consumption data and/or sensor data. For this purpose, an evaluation unit can be provided on the server, which evaluates the received data on the basis of the stored rule data set. The rule data set can also be changed dynamically during system operation.

The rules can be, for example: "if the sensor data falls below or exceeds a predefinable threshold value, the water quality is inadequate" or "if the sensor data lies within a predefinable interval and the water consumption data falls below a threshold value, the water quality is adequate". The preliminary result of such a determination can be issued on the server via the user interface (e.g. as an alert notification in the first example case above) and/or can be forwarded to the RO facility and the further device.

However, the preliminary results are based only on the measured values and the sensor data. To verify the preliminary results, another analysis is performed. For this purpose, the water sample is analyzed in an analysis device. The resulting data can then be provided. The result data can now be forwarded to the server in order to verify or prove the preliminary result. The resulting data is again sent out on the user interface of the server and/or forwarded to the RO facility or another device, as the case may be. The latter is carried out, in particular, if the quality is evaluated as inadequate, in order to take countermeasures as quickly as possible and, in particular, to detach the dialysis device from the water supply network. It is thus possible on the one hand to improve the quality of the assessment and on the other hand to provide conclusions about the quality independently of the laboratory-technical analysis. Thus, the RO facility can advantageously be monitored much more closely. Furthermore, conversely, the analysis results from the laboratory analysis may also be able to be specified by the sensor data and/or consumption data, or even be able to define or give a cause, if appropriate. The application for evaluation and verification, as described above, does not necessarily have to be executed on the server, but can also be transferred, for example directly onto the RO facility or the analysis device.

In a further advantageous embodiment of the invention, the system further comprises a water supply unit which is intended for delivering water into the RO installation and which comprises a measuring unit for measuring water consumption data, and wherein the measuring unit comprises a bus interface for transmitting the detected water consumption data (particularly preferably to the server). With these data, a more comprehensive evaluation process can be initiated and a broader result can be provided. Thus, for example, the analysis results can be correlated in time with the water consumption data, so that more profound conclusions can be made. For consumption values, e.g. water consumption per hour/day/week/treatment, limit values can be defined. If the limit is exceeded, a notification is generated. It is not clear why overrun is caused so far. If additional water quality data are present, for example the conductivity of the raw water or feed water, and if this value also shows an exceeding of the limit value, the cause can therefore be defined/determined by means of this intelligent correlation.

In a further advantageous embodiment of the invention, the result data in electronic form are detected in a predefinable standardized format. All result data can thus be processed uniformly on the server and/or received on the RO facility; even if the analysis device is run by different operators in different methods and/or applications. This improves the compatibility of the system and the connected system.

The sensor data detected by the sensor unit comprises parameters that represent the correct functioning of the RO plant. The parameters include parameters relating to the conductivity of the water, in particular two different parameters are detected here, namely upstream and downstream of the membrane (feed water conductivity, permeate conductivity), and parameters relating to the retention rate. The retention capacity R can be determined, for example, by means of the conductivity cSP of the feed water and the conductivity cP of the permeate as follows:

R[％]＝(cSp-cP)/cSp*100。

in an alternative embodiment of the invention, further parameters can also be detected in order to increase the significance of the analysis or evaluation at the server (for example, the electrical and water consumption of the water treatment facility, the water temperature, the water hardness, the chlorine concentration).

Furthermore, the object is achieved by an RO plant for producing ultrapure water having a sensor unit for detecting sensor data and an electronic data interface determined for use in the above-described safety system.

Furthermore, the object is achieved by an analysis device which can be configured, for example, in a laboratory having at least one laboratory-technical device for examining or analyzing the water quality of a water sample of an RO installation with regard to safety requirements (for example with regard to contamination) of ultrapure water, and wherein the analysis device is intended to generate electronic result data as a response to the analysis of the water sample, wherein the analysis device is further configured with an analysis interface in order to transmit the generated result data in electronic form to an external entity located outside the analysis device, and wherein the analysis device is intended for use in a safety system according to one of the above-mentioned aspects.

The object is also achieved by a server for the coordinated processing of security data of an RO facility which is operated for at least one medical technology device, in particular a dialysis device, wherein the server is intended for use in a security system as described above. The server is configured to have:

-an electronic data interface for exchanging digital data and/or analog data in order to receive sensor data detected by the sensor unit;

-an analysis interface for receiving result data generated by the analysis means in electronic form.

In an advantageous embodiment of the invention, the server is also formed with a memory for storing the received data and/or is formed to interact (intervert) with a database and/or comprises a processing unit for exclusively processing the received data. Therefore, the history data can be processed.

The object is also achieved by a method for the safety-technical testing of an RO installation, which is designed for the operation of at least one medical-technical device, in particular a dialysis device, having the following method steps:

-detecting sensor data during the determination of the RO plant operation for the preparation of ultrapure water;

-transmitting the detected sensor data in electronic form to an external communication partner. Therefore, the external communication party sets up outside the RO facility and outside the RO facility system, so that inspection independent of the RO facility can be ensured.

In a preferred embodiment of the invention, the water samples of the RO installation are analyzed with respect to safety requirements on the laboratory system after or in parallel with the transmission of the sensor data in order to generate result data on the basis of the analysis. The resulting data generated can be sent in electronic form and in particular to the above-mentioned devices for controlling the RO plant and/or the dialysis device. Alternatively, the RO plant and/or the dialysis apparatus can also be adjusted based on the result data.

In a preferred embodiment of the invention, the transmission of the detected sensor data takes place continuously or in a time-controlled manner during the operation of the RO installation and/or as a function of predefinable events.

In a further preferred embodiment of the invention, the sensor data and the result data are supplied to a server for central processing and storage there, and in particular to statistical evaluation across the RO facility.

In a further preferred embodiment of the invention, the result data are transmitted directly to at least one medical device for controlling the medical device, in order to be able to trigger an emergency interruption or emergency shutdown locally if necessary.

The invention also relates to a computer program product comprising a computer program. The computer program comprises a software code determined for performing the above-mentioned method. The computer program product can be implemented in software or in hardware and can comprise, in addition to a computer program, instructions for use, a data carrier and/or a package. In particular, the method steps of detecting, transmitting, generating result data and the transmission thereof are triggered and/or carried out by software. The analysis of the sample can include a number of work steps that sometimes require manual manipulation, while the generation of the resulting data can be performed fully automatically.

The terms used in the present application are defined below.

The RO system is a RO system for producing ultrapure water and is used with at least one medical-technical system for supplying the latter with ultrapure water. RO facilities can therefore also be referred to as medical technology facilities. The RO facility can include an electronic processing unit (e.g., in the form of a CPU, FPGA, microprocessor, or the like). The sensor unit can be implemented on an electronic processing unit. Standard ISO 13959: 2014 define the requirements for dialysis water (ultrapure water) to be complied with by the operators of the respective facilities. Here, it adopts the standard ISO 13959: 2014 "water for hemodialysis and related therapies", the standard for manufacturers of such facilities and the following requirements on the microbiological and chemical quality of the dialysis water are stipulated:

the correct functionality of RO facilities is defined inter alia by the retention rate of sodium chloride (common salt), which should lie between 90% and 99.8% according to the requirement profile for ultrapure water.

The RO facility and the laboratory system with the analysis device are installed and provided on two different, separate systems. Typically, RO facilities are provided in dialysis centers (e.g., in areas separate from the dialysis areas) in which dialysis machines are also operated. And the laboratory system is located in an external laboratory, which is located outside the dialysis center. The reason for this is that the performed analysis can also be performed independently (and thus unaffected) by the operator of the RO facility. Thereby avoiding a conflict of interests. The analysis device and the RO facility communicate via a data connection. The data connection can be based on the internet and can be based on the protocol of the http protocol family, for example. The RO facility and the laboratory system are on different platforms and run by different operators.

The analysis device can be a component of a laboratory system for examining water samples. The evaluation device is an electronic component and is used for digital data processing and data communication to an external communication entity. Thus, in addition to the analysis device, the laboratory system typically comprises at least one laboratory technical device or apparatus (e.g. a conductivity measurement apparatus, an ion chromatograph, a mass spectrometer or an atomic absorption spectrometer for quantitative determination of individual ions, etc.). Laboratory systems are used to detect contamination of water and to perform biological and/or chemical analyses and bacteriological examinations. Accordingly, one aspect of the present invention relates to the comprehensive analysis of water samples of RO facilities; thus, not only is the chlorine content detected, for example, but further examinations are carried out in order to detect contamination of the water (dirt, biological or bacterial impurities, etc.). The laboratory technical result is provided on the basis of an analysis performed by means of different above-mentioned devices and/or laboratory technical apparatuses. The results are fed to an evaluation device, which determines whether to automatically generate result data therefrom, for example in the form of an electronic message. The resulting data can be configured for transmission to an external communication party. The result data should be sent, in particular, via a data connection to the RO facility and/or cloud-based server and/or medical technology device, in order to be able to initiate further measures if necessary there.

The network is an electronic network for transmitting data. The network can operate with different protocols. The connection between the RO installation and the server can therefore be designed as an MBUS system (in particular according to the standard of the standard series EN 13757), and the evaluation device can communicate with the server and/or the medical-technical device via an IP-based protocol, for example by means of messages in an XML structure. For data exchange, the RO facility and/or the analysis device are configured with interfaces: an RO facility with a data interface (for example by means of an IP-based protocol) and an analysis device with an analysis interface (for example HL 7); via the interface, data can also be transferred in the form of a tabular data structure, for example in the format csv, Microsoft Excel or OpenOffice Calc or xml.

The resulting data generated can be forwarded in the form of a status notification (water quality is insufficient — water quality is sufficient) or in the form of a more extensive message packet including additional details about the analysis. The message packet can also include metadata such as a timestamp, sample status, duration of inspection, and the like.

As mentioned above, the system can comprise a server, preferably cloud-based. The detected and generated data are aggregated and preferably stored in a server. For this purpose, access to the connected database can be provided. The server can be used to coordinate processing of data. In this context, "harmonization" relates to the fact that the composite structure result data for the dialysis devices has been calculated, i.e. the result data has been calculated for the dialysis devices fed by the respective RO facilities. However, the coordinated computation can also take place locally on the dedicated device, and can nevertheless be performed centrally and for all devices in the composite structure.

On the server, evaluation means in the form of an evaluation application (software) or evaluation circuitry (hardware) can be formed. The evaluation device is an electronic component. The evaluation circuit can be designed, for example, as an electronic circuit with digital and/or analog circuit components, which can comprise evaluation logic. The evaluation logic is for evaluating what quality level the analyzed RO facility is in compliance with in order to issue an alert notification in case of non-compliance. The alarm notification can be issued via a corresponding data interface to the RO facility, to a control unit of the RO facility and/or directly to the medical technology device (dialysis device). In order to signal directly, a traffic light function can be issued on the user interface (red indicating too low a quality, green indicating sufficient quality, and yellow indicating an alarm or an intervention level being exceeded, for example as a function of exceeding or falling below a relevant limit value). The evaluation circuit is able to access a set of rules for evaluation, which can be stored in particular in the form of rules in a database or memory and define a policy for prioritizing a certain amount of result data. The evaluation circuit can preferably be activated automatically if new result data are generated or forwarded. The resulting data is preferably sent to the recipient according to the PUSH protocol for regulatory and/or control purposes. The recipient can be an RO facility or a dialysis device.

The assessment is preferably associated with a particular RO facility. The results across RO facilities can also be provided by means of statistical evaluation if a central server is used that collects data from all or selected RO facilities (e.g., from all facilities in a particular geographic area or dialysis complex) and evaluates them. It is also possible to compose an evaluation which is then able to resolve the notification for the facility (e.g. via a corresponding identification indication) by the RO facility identification.

An important aspect of the present solution is that the medical-technical devices of the safety system, which comprise the RO installation, the laboratory system with the analysis device and can furthermore comprise a water supply unit and/or a dialysis device, are connected via two different connections:

1. a data connection for exchanging electronic messages and digital data, such as sensor data and/or result data, an

2. Piping connections for exchanging physical media, such as ultrapure water and/or water samples.

A higher level of security can be improved by additional checking measures. This is that: sensor data detected locally at the RO facility (locally, in a computing unit of the RO facility, or externally in a computing unit on a server or analysis device) is first evaluated in order to provide preliminary results. The preliminary results are then provided to an analysis device, if necessary, and confirmed (verified) or rejected (certified) by the analysis of the water sample. The preliminary results can therefore be provided earlier on the RO plant. Furthermore, security can be improved by checking the preliminary result again.

In the following, the invention is described for a dialysis apparatus, for example a hemodialysis apparatus, as an example of a medical technical apparatus. However, it is obvious to the person skilled in the art that the invention can equally be applied and transferred to other medical-technical, computer-controlled devices or (fluid-management) machines or blood-treatment devices which require ultrapure water for operation. This can also be applied, for example, to peritoneal dialysis equipment if it treats ultrapure water.

It is possible to transmit sensor data of the RO plant and/or consumption data of the water supply or other devices (e.g. with respect to gas consumption, current consumption, consumption of temperature resources for heating or cooling, etc.) in configurable time intervals for processing by the evaluation application.

In a preferred embodiment of the invention, it is configurable to which device the result data are to be sent. It can thus be provided, for example, that if the data contains a high-priority alarm notification (water quality deficiency), the data is sent to the monitoring unit of the hospital/operator and to another entity, and in good cases (sufficient quality) only to the server and/or the relevant RO facility. This has the advantage that facilities running without errors are not loaded with unnecessary notifications. However, it can also be expected and configured that all result types are always available on all devices. Thus, the operator (of the clinical device and/or RO facility) is always able to automatically view all facilities and the status of the facilities at a glance.

A further object solution consists in a computer program product which can be loaded into a memory of a computer or an electronic or medical technical device or which can be loaded with a computer program for carrying out the method described in detail above if the computer program is executed on a computer or an electronic or medical technical device.

A further object solution provides a computer program for carrying out all the method steps of the method described in detail above, if the computer program is executed on a computer, an electronic or a medical technical apparatus. It is also possible here to store the computer program on a medium that is readable for a computer or an electronic or medical device.

Drawings

Non-limiting understanding of embodiments and features and additional advantages thereof are discussed in the following detailed description of the drawings and with the aid of the accompanying figures.

Fig. 1 shows a schematic representation of a safety system according to the invention with an RO system and a server for operating a dialysis system and the exchange of data thereof, according to an advantageous embodiment of the invention.

Fig. 2 shows a flow chart of a method according to a preferred embodiment of the invention.

FIG. 3 shows schematically the exchange of data between a dialysis device and a server and an RO system according to a preferred embodiment of the invention, and

fig. 4 shows an alternative embodiment of the invention of the security system without a server with respect to the embodiment in fig. 1.

Detailed Description

In the following, the invention is described in detail with the aid of embodiments with reference to the accompanying drawings.

The invention relates to an electronic message system for RO facilities RO, which are operated and applied for dialysis stations or other medical technology devices D having at least one dialysis device and which communicate the quality status of the RO facilities RO.

Fig. 1 shows a first embodiment of the invention, wherein a system 1 comprises a server SV. The server SV can be at least partly configured for evaluating water quality data. The evaluation of the water quality is based on different input variables provided by different devices (RO facility RO, analysis device AE, database DB, etc.).

For this purpose, a safety system 1 is provided, which comprises a plurality of medical technical apparatuses, including medical technical devices, each having electronics for data processing and for communication.

The RO plant RO is intended for the production of ultrapure water which has to be supplied to one or, as a rule, a plurality of dialysis devices D of a dialysis station, whereby the latter can be operated. In order to ensure that the quality of the pure water delivered is sufficient (respect to the limit values for contaminants, such as aluminum, chlorine, fluorine, nitrate, sulphate and/or zinc-the limit values for the respective maximum concentrations being defined as described above in the standard ISO 13959: 2014) -the RO plant RO is constructed with a sensor unit S for detecting sensor data (in fig. 1, sensors S1, S2, Sn are exemplary.) furthermore, the RO plant RO comprises an electronic data interface RO-S for transmitting the sensor data detected by the sensor unit S.

The RO facility RO is fed by a water supply unit W for delivering water, whereby the water can be cleaned or treated in the RO facility RO. The water supply unit W comprises a plurality of electronic modules, such as in particular a measuring unit M, which is intended to determine the water consumption data 32. For this purpose, different measuring methods and sensors or signal sensors can be used. Furthermore, the water supply unit W comprises an interface for data communication, which can be formed in particular in the form of an MBUS interface MBUS. Other medical-technical devices of the system 1, such as the server SV and/or the analysis device AE, can communicate with the water supply unit W via the interface MBUS. It is therefore possible for the evaluation device AE to be able to detect the sensor data directly from the water supply unit W. This has the following advantageous effects: the evaluation device AE can carry out a more extensive evaluation, which takes into account in particular the water consumption data 32 and, if necessary, further sensor data detected on the water supply unit W for calculating result data.

In a further advantageous embodiment of the invention, the sensor data detected on the water supply unit W can be forwarded to the RO facility RO. This has the advantage that the sensor data of the water supply unit W can be calculated by means of locally detected sensor data of the RO plant as a preliminary result, which can be sent to the analysis means for verification. The preliminary result can be output on an output unit (e.g., screen) of the water supply unit W and/or the RO facility RO for local control. It is thus possible to perform a wider calculation of the preliminary result, which is more convincing.

The analysis device AE can be arranged in a laboratory system. Laboratory systems with laboratory-technical devices are intended for analyzing water samples of RO facilities with regard to safety requirements and in particular with regard to contamination. Based on the analysis results, and if necessary taking into account additionally detected sensor data (from the water supply unit W and/or from the RO facility RO), the result data is calculated or generated according to the provided rules. The result data is also provided in a digital format, in particular in a result format. The format can be a configurable data structure, in particular according to the XML format. Furthermore, the evaluation device AE comprises an evaluation interface AE-S in order to transmit the resulting data in electronic form to an external communication partner (in particular to the RO facility RO and/or to the connected dialysis device D).

The devices and apparatuses of the security system 1 are connected to each other via a network NW.

As shown in fig. 1, a plurality of dialysis devices D and/or further apparatuses are usually connected to the RO installation. This is indicated in fig. 1 by the two exemplary devices D1, Dn.

The security system 1 comprises a server SV in the (first) preferred embodiment of the invention shown in fig. 1. The server is preferably centrally accessible via a technical communication network NW via a network interface and can be configured as a cloud server. The server SV exchanges data with the connected devices, in particular with the RO facility RO, the medical-technical device D, the evaluation device AE and, if necessary, the database DB. In the first embodiment of the invention, an evaluation application or evaluation functionality is implemented in the processor P on the server SV, which evaluation application or evaluation functionality is determined for evaluating the detected data. In particular, the result data and the sensor data and, if necessary, the historical data coming out of the database DB are processed according to predefinable rules in order to indicate a result message about the quality status of the water provided by the RO plant. The result message can preferably be used for controlling the RO facility RO and/or the connected dialysis device D. Thus, the relevant results can be provided directly locally at the time of use.

In a preferred embodiment of the invention, configurable rules can also be stored in the database, which specify: when to send the result data to the corresponding recipient. Furthermore, it is possible to define, for example exclusively for a specific geographical area or country: which further functions and messages are sent to the recipient together with the result data in the data packet. The function can be, for example, a control function for the dialysis device and/or the RO installation (switching the dialysis device on and off, limiting the device functionality, in particular depending on the analysis result, etc.), and the message can be the creation of an alarm notification (for example, indicating on the RO installation that the water quality does not meet the required safety requirements in the event of an indication that a limit value is exceeded). The rules can be specified differently in the configuration phase specifically for the respective recipient or group of recipients of the result data (or data packet). Thus advantageously achieving another important flexibility.

The server SV and the evaluation application executed thereon are preferably able to be provided as a Web platform and browser-based. The server SV can access the local memory MEM for further calculations, such as statistical evaluation, and/or for storing the calculated or read-in data there.

As already briefly explained above, the evaluation device AE is intended to generate result data from laboratory reports or laboratory results according to a predefined format in order to transmit said result data to an external communication partner.

In fig. 1, arrows (from the water supply unit W to the RO facility RO and from the RO facility to the analysis device AE) indicated by broken lines indicate that: in this case, data transfer is not involved, but rather the transfer of the physical medium, i.e. in the first case water is transferred to the RO facility RO, and in the second case the water sample is transferred to the analysis device AE. The other arrows represent electronic exchanges of analog and/or digital data.

In principle, the system can be operated in two embodiment variants.

As described above, in the first embodiment variant shown in fig. 1, a central server SV is switched on for the system 1. An evaluation application for evaluating the detected data is then executed on the server SV. The server SV is preferably cloud-based and accessible via an interface based on an IP protocol (e.g. TCP/IP) SV-S1, SV-S2. In this embodiment of the invention, the exchanged data are first transmitted from the respective sender (e.g. RO facility RO, analysis device AE) to a central server SV, which then transmits the received data directly or in a preprocessed form to the respective receiver (e.g. RO facility RO, analysis device AE). For this purpose, data from the water supply unit W and/or data of the dialysis device D can also be communicated via the interfaces SV-S1, SV-S2 (not explicitly shown in FIG. 1). Thus, in this embodiment, the server SV acts as a proxy server or intermediate node in the chain between the data source and the data sink. This embodiment of the invention has the following advantages: all data can be aggregated on the server SV so that further evaluation and processing can be performed. Thus, the historical data set can be compared, among other things, to the current data set so that further conclusions can be provided (e.g., "samples are taken from a group of RO facilities located in a particular geographic area in the case that the result data indicates an insufficient water quality" or "samples are taken in a particular time phase in the case that the result data indicates an insufficient water quality". The statistical evaluation across RO facilities can be performed, among other things.

In a second embodiment of the present invention, no central server is provided. In this case, the RO plant and/or the water supply unit W and/or the dialysis apparatus D directly interact with the analysis device AE and vice versa. The second embodiment is to be represented in fig. 1 as follows: at least the RO facility RO communicates directly (without intervention by the server SV) with the evaluation device AE, which is indicated by the arrows between the respective interfaces RO-S, AE-S, which operate without intervention by the server SV. In this case, an evaluation application for evaluating the data and for calculating the result message can be provided at least in part on the evaluation device AE. The application can also be partially implemented on other electronic devices. The result data or the result message then comprise a control data set which is designed to control the respective device. In a fault situation (ultra pure water is of insufficient quality), the control data set can contain sections that for example trigger the issuance of an alarm notification and/or the shutdown of the RO facility RO. Furthermore, the control data set can contain a notification area that triggers a notification to another entity or device. The notification should be generated in particular when the control data set has been transmitted to the external communication partner, for example to the RO facility RO. Thus, for example, an alarm notification can be automatically triggered directly and locally on the dialysis device D, which is connected to the RO facility RO. This has the following advantages: in the case of safety-critical, the relevant information is provided directly locally, so that the necessary measures can be initiated directly without the need to inform the intermediate entity. In an advantageous variant, it is proposed that the result data or result messages must be released by a user (for example, a laboratory consultant) before they are forwarded to further devices and entities. This can be performed via the provided area and the user input detected thereon. The release can be associated to different roles (with specific qualifications) of the user.

This embodiment is described in detail below with the aid of fig. 4.

Fig. 2 shows a flow of a method according to a preferred embodiment of the invention. After the method for the safety-technical quality check of the RO facility RO and thus the normal operation D of the connected dialysis device has started, the sensor data are detected in step 100 during the operation of the RO facility RO. This preferably takes place at predefinable time intervals after a preconfigured event (for example, upon connection of another dialysis device D and/or after a certain number of dialysis sessions) and/or continuously during the RO run. In step 200, sensor data detected on the RO facility RO and/or the water supply unit W is transmitted in electronic form to the external communication party (outside the RO facility). According to one of the two embodiment variants described above, the sensor data is forwarded to a server SV or an evaluation device AE. The analysis device AE furthermore receives the water sample and analyzes it in order to be able to provide the result data. This is done in step 300. In a subsequent step 400, the generated result data are forwarded in electronic form directly to the respective device RO, D and/or transmitted to the server SV for controlling the RO facility and/or the medical technology device D. The result data are then forwarded with intervention from the server SV and can also be stored centrally in the server. Thus, a first RO facility RO can also access reference data from other second RO facilities in a similar fashion. Thereafter, the method can be iteratively performed or ended.

Fig. 3 shows a sequence diagram with these two different variants described above for the exchange of data between the electronic units of the system 1:

1. having a central server SV and an evaluation application (dashed line) executing thereon;

2. without a server (solid line). In this case, the RO installation and the dialysis device D as well as the measurement unit M interact directly with an evaluation application, which is executed in this case on the evaluation device AE.

During the operation of the RO installation, the sensor data 31 are detected locally and are forwarded from there directly to the evaluation device AE (solid arrow). Alternatively, the sensor data 31 are first transferred to the server SV and from there to the evaluation device AE (shown in fig. 3 by a dashed and dotted line). In parallel or simultaneously, water consumption data 32 are detected on the measuring unit M or another device of the water supply unit W, which in a first variant are forwarded to the server SV for evaluation (shown in fig. 3 in dash-dot lines). Alternatively or cumulatively, the water consumption data 32 can also be forwarded to the evaluation device AE (solid line). In this case, an evaluation application is executed on the evaluation device AE to evaluate the data, so that the corresponding functionality of the server SV is in this case transferred to the evaluation device AE (schematically illustrated in fig. 4). The evaluation device AE generates a result data set 33 on the basis of the laboratory examinations or analyses carried out, which result data set is now likewise forwarded directly to the medical-technical device RO, D, W (solid lines) or, in other embodiment variants, via the intervention and/or storage of the server SV, which then forwards the data in processed or unprocessed form to the recipient RO, D, W (shown in fig. 3 as a dot-dash line). The processing and evaluation at the server SV can comprise further process steps, as described above, for example statistical evaluation or comparison with historical data. Further results of these process steps are indicated in fig. 3 with reference numeral 33' and can be forwarded to the respective local entity RO, W, D.

Fig. 4 schematically shows an embodiment in which the system operates without a server. The dashed line (W- > RO, RO- > AE) does not-as in FIG. 1-also represent a data exchange but a transfer of the physical product (water, ultrapure water). With regard to the data exchange, the RO installation RO and the analysis device AE, and if necessary the water supply unit W, interact directly with one another via a network, which can be based on TCP/IP, for example. In this embodiment of the invention, the functionality that was already implemented on the server SV in the first exemplary embodiment is implemented on the evaluation device AE. The data of the water supply unit W or its measuring unit M, the sensor data of the RO plant RO and, if appropriate, the data of the dialysis device D are sent directly to the evaluation device AE and processed there. It is also possible that the water supply unit W is connected to the RO facility RO via a data interface. The data detected on the water supply unit W can then be sent indirectly and via the intervention of the RO facility RO to the analysis means AE. In order to process the read data on the analysis device AE, the reference data can be read from the database DB, and conversely, the data detected by the analysis device AE and the processed data can be stored in the database DB. The analysis results are then forwarded to the RO facility (dashed line), which then forwards the data to the water supply unit W and the dialysis device D (likewise dashed line), or the data can be sent directly from the analysis device AE to the dialysis device D and/or the water supply unit W for control (this embodiment is represented by the solid arrow in the figure).

Finally, it is pointed out that the description and embodiments of the invention in principle should not be understood as being limited to a particular physical implementation of the invention. All the features illustrated and shown in connection with the various embodiments of the invention can be provided in different combinations in the subject-matter according to the invention in order to achieve their advantageous effects simultaneously. Thus, for example, also within the scope of the invention, other central units, such as a database DB, are provided, alternatively or cumulatively, with respect to the server SV. Likewise, in addition to the dialysis device D, a further medical technology device and/or a computer-assisted device (also a mobile terminal device) can be connected to the RO facility RO, on which the result data are output. It is particularly obvious to the person skilled in the art that the invention can be used not only for dialysis devices but also for other medical technology devices D for which the operation requires ultrapure water from the RO facility RO. Thus, monitoring the quality of ultrapure water can also be used in sterilization and cleaning processes, for example, to sterilize clinical instruments.

Furthermore, the components or modules of the safety system for monitoring the quality of ultrapure water can be implemented in a distributed manner on a plurality of physical products. Thus, for example, within the scope of the invention, the application for evaluating the result data is provided completely or partially on the evaluation device AE or is executed completely or partially on the server SV. Furthermore, the sections of the computer program for carrying out the method can also be executed directly on the medical technology device D, RO.

The scope of protection of the invention is given by the claims and is not limited by the features set forth in the description or shown in the drawings.

List of reference numerals:

d medical device, in particular dialysis device

SV server

P evaluation device

MEM memory

RO reverse osmosis installation, RO installation for short

AE analysis device

Analysis interface of AE-S analysis device

Data interface for RO-S RO facility

W water supply unit

Measuring unit of M water supply unit

Bus interface of MBUS water supply unit

100 detecting sensor data

200 sending sensor data detected on an RO facility

300 generate result data

400 transmit result data

DB database

NW network

Claims

1. Electronic safety system for a RO installation (RO) designed for use with at least one medical device (D), in particular a dialysis device, having:

-the RO plant (RO) determined for the preparation of ultrapure water and constituted with a sensor unit (S) for detecting sensor data, and wherein the RO plant (RO) comprises an electronic data interface (RO-S) for sending sensor data detected by the sensor unit (S);

-a laboratory system having at least one laboratory technical device and an analysis device (AE), wherein at least one of the laboratory technical devices is intended for analyzing water samples of the RO plant with respect to safety requirements and in particular with respect to contamination, and wherein the analysis device (AE) is intended for generating result data on the basis of the analysis of at least one of the laboratory technical devices, wherein the analysis device (AE) is further designed with an analysis interface (AE-S) in order to transmit the generated result data in electronic form;

-a Network (NW) for data exchange between the medical technology devices of the security system, in particular between the RO facility (RO) and the analysis device (AE).

2. Safety system according to claim 1, wherein the system comprises a Server (SV) which determines the sensor data for receiving the RO facility (RO) and/or the result data of the analysis means (AE) and which also determines the result data for forwarding to the RO facility (RO) and/or the medical technology device (D) for control and/or regulation.

3. The safety system according to any of the preceding claims, wherein the system further comprises a water supply unit (W) determined for delivering water into the RO plant (RO), and wherein the water supply unit (W) comprises a measurement unit (M) for measuring water consumption data, and wherein the measurement unit (M) comprises a bus interface (MBUS) for transmitting the detected water consumption data.

4. A safety system according to any preceding claim, wherein the sensor data comprises a parameter relating to conductivity and/or a parameter relating to retention.

5. Safety system according to any one of the preceding claims, wherein preliminary results are calculated locally from the detected sensor data, said preliminary results being sent to the analysis means (AE) for verification or plausibility in the evaluation means (AE) based on the received water samples.

6. RO plant (RO) for the preparation of ultrapure water, having a sensor unit (S) for detecting sensor data and an electronic data interface (RO-S) intended for use in a safety system according to any one of the preceding claims.

7. Analysis device (AE) for a laboratory system having at least one laboratory technical device for analyzing water samples with respect to safety requirements, wherein the analysis device (AE) is intended to generate result data on the basis of the analysis of the water samples and to transmit the result data in electronic form via an analysis interface (AE-S), and wherein the analysis device is intended to be used in a safety system according to one of the preceding claims.

8. A Server (SV) for the coordinated handling of security data of an RO facility (RO) operating for at least one medical technology device (D), in particular a dialysis device, wherein the Server (SV) is intended for use in a security system (1) according to the above system claim, the server having:

-an electronic data interface (SV-S1) for receiving sensor data detected by the sensor unit (S);

-an analysis interface (SV-S2) to receive in electronic form the result data generated by the analysis means.

9. Server (SV) according to the preceding claim, wherein the Server (SV) further comprises a memory (MEM) for storing the received data and/or interacts with a Database (DB) and/or comprises evaluation means (P) to further process the received data.

10. Server (SV) according to any of the preceding claims for said server, wherein said Server (SV) further comprises a control interface for controlling said RO facility (RO) and/or one or more of said medical technology devices (D) based on said result data.

11. Method for the safety check of an RO installation, which constitutes an application for the use of at least one medical technology device (D), in particular a dialysis device, having the following method steps:

-detecting (100) sensor data during the determination of the RO plant (RO) operation for the preparation of ultrapure water;

-sending (200) the detected sensor data in electronic form to an external communication party;

-receiving result data representing an analysis of water samples of the RO facility with respect to safety requirements.

12. The method according to the preceding method claim, wherein the detection (100) of the sensor data is performed continuously or time-controlled during operation of the RO plant and/or after a predefinable event.

13. Method according to any of the preceding method claims, wherein the sensor data and the result data are transported to a Server (SV) for central processing and storage there, and in particular to statistical evaluation across RO facilities.

14. Method according to any of the preceding method claims, wherein the result data is sent directly to the medical technology device (D) and/or the RO facility (RO) for respective control thereof, and optionally emergency abort can be triggered locally.

15. Computer program product with a computer program having program sections for performing all the method steps of the method according to one of the preceding method claims, if the computer program is executed on a computer or an electronic device.